MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3789

Device Problem Unexpected Shutdown (4019)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Event date is unknown.

Event Description

It was reported that the patient's ipg was shutting off randomly.Troubleshooting was done and impedances were in normal range.As a result, surgical intervention may occur to address the issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: PROTEGE IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• MDR Report Key: 11326164
• MDR Text Key: 231945870
• Report Number: 3006705815-2021-00560
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020833
• UDI-Public: 05415067020833
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 3789
• Device Catalogue Number: 3789
• Device Lot Number: 5003158
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/14/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86